FDA Drug recall D-1034-2014
Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only
- FDA Drug
- Class II
- terminated
- Published 2014-01-29
On 2014-01-29 the FDA classified a Class II recall of Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only by Fresenius Kabi Usa, citing presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1034-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-31 |
| Published | 2014-01-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061. NDC 14789-500-10.
Reason
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
Identifiers
| code_info | National Drug Code (NDC): 63323-563-10; Lot Numbers and (Expiration Dates): 011713 (01/2015); 012213 (01/2015), 0329…National Drug Code (NDC): 63323-563-10; Lot Numbers and (Expiration Dates): 011713 (01/2015); 012213 (01/2015), 032913 (03/2015), 041613 (04/2015); 042513 (04/2015), 042613 (04/2015), 052213 (05/2015), 092612 (09/2014), 111512 (11/2014) NDC: 14789-500-10; 122911 (12/2013), 123011 (12/2013) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1034-2014%22
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